Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals, 2011.

摘要

Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA) (110 P.L. 316; 122 Stat. 3509) amended section 512 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b) to require that sponsors of applications for new animal drugs containing an antimicrobial active ingredient submit an annual report to the Food and Drug Administration on the amount of each such ingredient in the drug that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. This legislation was enacted to assist FDA in its continuing analysis of the interactions (including drug resistance), efficacy, and safety of antibiotics approved for use in both humans and food- producing animals (H. Rpt. 110-804). Each report submitted to the FDA must specify: (1) the amount of each antimicrobial active ingredient by container size, strength, and dosage form; (2) quantities distributed domestically and quantities exported; and (3) a listing of the target animals, indications, and production classes that are specified on the approved label of the product. Sponsors of antimicrobial drug products that are approved and labeled for more than one food-producing animal species are not required to report sales and distribution information for each individual animal species. Only total product sales information is required. Each years report provides monthly sales and distribution data for the preceding calendar year